About MFDA

The Maldives Food and Drug Authority (MFDA) is the regulatory body responsible for ensuring the safety, quality and efficacy of food, drugs, medical devices, and cosmetics in the Republic of Maldives. Established in 2016, MFDA operates under the Ministry of Health and serves as the national authority for regulation of food and drugs in the country.

MFDA was created through the consolidation of several previously fragmented regulatory functions, creating a unified approach to food and drug regulation. This consolidation has allowed for more coordinated enforcement of regulations and better protection of public health across the Maldives.

As part of the global network of national regulatory authorities, MFDA aligns its activities with international best practices and standards established by organizations such as the World Health Organization (WHO), the Food and Agriculture Organization (FAO), and the International Conference on Harmonization (ICH).

Mission

To protect and promote public health through effective regulation, ensuring the availability of safe, quality, and efficacious food, drugs, medical devices, and cosmetics throughout the Maldives through science-based decision making and transparent regulatory processes.

Vision

To be recognized as a leading regulatory authority in the region, providing a robust regulatory framework that ensures the safety and quality of regulated products while promoting innovation and access to essential products for the Maldivian population.

Key Functions

MFDA performs a wide range of regulatory functions to ensure that food, drugs, medical devices, and cosmetics available in the Maldives meet appropriate safety, quality, and efficacy standards. These functions are designed to protect public health while facilitating access to necessary products.

Product Registration & Approval

Evaluating and approving food products, pharmaceuticals, medical devices, and cosmetics for the Maldivian market before they can be imported, distributed, or sold.

Laboratory Testing

Conducting and supervising laboratory analyses of regulated products to verify compliance with established standards.

Market Surveillance

Monitoring products in the market through inspections, sampling, and post-market surveillance to ensure ongoing compliance.

Licensing & Inspection

Issuing licenses to manufacturers, importers, distributors and conducting periodic inspections of licensed facilities.

Adverse Reaction Monitoring

Operating pharmacovigilance and food safety surveillance systems to detect and respond to adverse events.

Information Dissemination

Providing accurate and timely information to healthcare professionals, consumers, and industry stakeholders.

Regulatory Framework

MFDA operates under a comprehensive regulatory framework comprised of laws, regulations, and guidelines designed to ensure public health protection while facilitating industry compliance. The authority's regulatory approach is based on science, risk assessment, and international best practices.

Legislation

MFDA's powers and functions are derived from the Food and Drug Authority Act of Maldives, which provides the legal foundation for the regulation of food, drugs, medical devices, and cosmetics throughout the country. This legislation is complemented by sector-specific regulations and technical guidelines.

Standards and Guidelines

MFDA has developed and adopted numerous technical standards and guidelines aligned with international norms. These include:

  • Food safety standards based on Codex Alimentarius guidelines
  • Pharmaceutical quality standards aligned with WHO and USP guidelines
  • Medical device safety requirements based on IMDRF principles
  • Cosmetics safety standards consistent with ASEAN guidelines

Enforcement Mechanisms

MFDA employs a proportionate and risk-based approach to enforcement, utilizing a range of measures to ensure compliance. These include issuing compliance notices, administrative fines, product recalls, suspending or revoking licenses, and, when necessary, pursuing legal action against serious violations.

Services

MFDA provides a range of services to industry stakeholders, healthcare professionals, and consumers. These services are designed to facilitate compliance with regulations while ensuring access to safe and quality products.

For Industry

  • Product registration and approval services
  • Licensing of manufacturers, importers, and distributors
  • Good Manufacturing Practice (GMP) certifications
  • Regulatory guidance and consultation
  • Pre-market assessment of product labeling and promotional materials
  • Training programs on regulatory requirements

For Healthcare Professionals

  • Drug information and safety alerts
  • Pharmacovigilance reporting systems
  • Therapeutic guidance and formulary support
  • Continuing education on medicines and medical devices

For Consumers

  • Consumer complaint handling and response
  • Public advisories on product safety concerns
  • Fraudulent product reporting mechanisms
  • Educational materials on safe product use
  • Online verification systems for registered products

Consumer Information

MFDA is committed to empowering consumers with information to make informed choices about regulated products. The authority regularly publishes educational materials, safety alerts, and guidance documents to help consumers understand their rights and responsibilities regarding food, drugs, medical devices, and cosmetics.

Product Verification

Consumers can verify whether a product is registered with MFDA by using the online product verification system on the MFDA website or by contacting MFDA directly. This helps consumers ensure they are purchasing products that have undergone appropriate safety assessments.

Reporting Concerns

Consumers who experience adverse reactions to drugs or suspect that a food, drug, medical device, or cosmetic product is unsafe or of poor quality are encouraged to report these concerns to MFDA through the consumer complaint hotline or online reporting system.

Safety Tips for Consumers

  • Always purchase food, drugs, and cosmetics from licensed establishments
  • Check for MFDA registration markings on regulated products
  • Verify expiry dates before purchasing or using products
  • Report any adverse reactions or product quality issues to MFDA
  • Follow storage and usage instructions on product labels
  • Be cautious of products marketed with unrealistic health claims

Frequently Asked Questions

How can I verify if a product is registered with MFDA? +
You can verify product registration using the online verification tool on the MFDA website by entering the product name or registration number. Alternatively, you can contact MFDA through the consumer hotline or email for assistance.
What should I do if I experience an adverse reaction to a medication? +
If you experience an unexpected or severe reaction to medication, you should first seek immediate medical attention. After receiving medical care, report the adverse reaction to MFDA through the pharmacovigilance reporting system or consumer hotline. This helps MFDA monitor medication safety.
How can I report a food poisoning incident? +
If you suspect you have experienced food poisoning, seek medical attention if symptoms are severe. Report the incident to MFDA through the consumer complaint hotline or online reporting system, providing details about the suspected food, where it was purchased, and your symptoms. MFDA will investigate the report to prevent further cases.
What products require MFDA registration? +
MFDA registration is required for pharmaceutical products, medical devices, cosmetics, and certain categories of food products before they can be imported, manufactured, distributed, or sold in the Maldives. Specific registration requirements vary by product category, so consult MFDA guidelines for detailed information.

Contact Information

MFDA maintains offices in Mal and provides multiple channels for stakeholders to access its services and information.

Headquarters

Haveeru Building, 5th Floor
Ameer Ahmed Magu
Mal, Republic of Maldives

Contact Details

Phone: +960 332 0000
Email: info@mfda.gov.mv
Website: www.mfda.gov.mv

Operating Hours

Sunday-Thursday: 8:00 AM - 4:00 PM
Friday-Saturday: Closed
Lunch Break: 1:00 PM - 2:00 PM

Emergency Contacts

Food Safety Emergency: +960 332 0011
Drug Safety Emergency: +960 332 0012
Consumer Complaints: +960 332 0013

Departmental Contacts

Food Regulation Department

Email: food.dept@mfda.gov.mv
Phone: +960 332 0021

Drug Regulation Department

Email: drug.dept@mfda.gov.mv
Phone: +960 332 0022

Medical Devices Department

Email: devices.dept@mfda.gov.mv
Phone: +960 332 0023

Cosmetics Regulation Department

Email: cosmetics.dept@mfda.gov.mv
Phone: +960 332 0024